FDA 510(k) Application Details - K043405

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K043405
Device Name	Spinal Vertebral Body Replacement Device
Applicant	NUVASIVE, INC. 4545 TOWNE CENTRE COURT SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	LAETITIA COUSIN Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	MQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2004
Decision Date	02/07/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review